Acquisitions and spin-offs dominated headlines in 2019 and the tone was set very early with Bristol-Myers Squibb acquiring
New Jersey-based cancer drug company Celgene in a US$ 74 billion deal announced on
January 3, 2019. After factoring
in debt, the deal value ballooned to about US$ 95 billion, which according
to data compiled by Refinitiv, made it the largest healthcare deal on
record.
In the summer, AbbVie Inc,
which sells the world’s best-selling drug Humira, announced its acquisition of Allergan Plc, known for Botox and other cosmetic
treatments, for US$ 63 billion. While the companies are still awaiting
regulatory approval for their deal, with US$ 49 billion in combined 2019
revenues, the merged entity would rank amongst the biggest in the industry.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
The big five by pharmaceutical sales — Pfizer,
Roche, J&J, Novartis and Merck
Pfizer
continued
to lead companies by pharmaceutical sales by reporting annual 2019 revenues of
US$ 51.8 billion, a decrease of US$ 1.9 billion, or 4 percent, compared to
2018. The decline was primarily attributed to the loss of exclusivity of Lyrica in 2019,
which witnessed its sales drop from US$ 5 billion in 2018 to US$ 3.3 billion in
2019.
In 2018, Pfizer’s then incoming CEO Albert Bourla had mentioned that the company did not see the need for any large-scale M&A activity as Pfizer had “the best pipeline” in its history, which needed the company to focus on deploying its capital to keep its pipeline flowing and execute on its drug launches.
Bourla stayed true to his word and barring the acquisition of Array Biopharma for US$ 11.4 billion and a spin-off to merge Upjohn, Pfizer’s off-patent branded and generic established medicines business with
Mylan, there weren’t any other big ticket deals which were announced.
The
Upjohn-Mylan merged entity will be called Viatris and is expected to have 2020
revenues between US$ 19 and US$ 20 billion
and could outpace Teva to
become the largest generic company in the world, in term of revenues.
Novartis, which had
followed Pfizer with the second largest revenues in the pharmaceutical industry
in 2018, reported its first full year earnings after spinning off its Alcon eye
care devices business division that
had US$ 7.15 billion in 2018 sales.
In 2019,
Novartis slipped two spots in the ranking after reporting total sales of US$
47.4 billion and its CEO Vas Narasimhan continued his deal-making spree by buying New
Jersey-headquartered The Medicines Company (MedCo) for US$ 9.7
billion to acquire a late-stage cholesterol-lowering
therapy named inclisiran.
As Takeda Pharmaceutical Co was
busy in 2019 on working to reduce its debt burden incurred due to its US$ 62
billion purchase of Shire Plc, which was announced in 2018, Novartis also purchased
the eye-disease medicine, Xiidra, from the Japanese drugmaker for US$ 5.3 billion.
Novartis’ management also spent a considerable part of 2019 dealing with data-integrity concerns which emerged from its 2018 buyout of AveXis, the
gene-therapy maker Novartis had acquired for US$ 8.7 billion.
The deal gave Novartis rights to Zolgensma,
a novel treatment intended for children less than two years of age with the
most severe form of spinal muscular atrophy (SMA). Priced at US$ 2.1 million,
Zolgensma is currently the world’s most expensive drug.
However,
in a shocking announcement, a month after approving the drug, the US Food and
Drug Administration (FDA) issued a press release on
data accuracy issues as the agency was informed by AveXis that
its personnel had manipulated data which
the FDA used to evaluate product comparability and nonclinical (animal)
pharmacology as part of the biologics license application (BLA), which was
submitted and reviewed by the FDA.
With US$
50.0 billion (CHF 48.5 billion) in annual pharmaceutical sales, Swiss drugmaker
Roche came in at number two position in 2019
as its sales grew 11 percent driven by
its multiple sclerosis medicine Ocrevus, haemophilia drug Hemlibra and cancer medicines Tecentriq and Perjeta.
Roche’s newly introduced medicines generated US$ 5.53 billion (CHF 5.4 billion) in growth, helping offset the impact of the competition from biosimilars for its three best-selling drugs MabThera/Rituxan, Herceptin and Avastin.
In late 2019, after months of increased
antitrust scrutiny, Roche completed
its US$ 5.1 billion acquisition of Spark Therapeutics to strengthen its presence in
gene therapy.
Last year, J&J reported almost flat worldwide sales of US$ 82.1 billion. J&J’s pharmaceutical division generated US$ 42.20 billion and its medical devices and consumer health divisions brought in US$ 25.96 billion and US$ 13.89 billion respectively.
Since J&J’s consumer health division sells analgesics, digestive health along with beauty and oral care products, the US$ 5.43 billion in consumer health sales from over-the-counter drugs and women’s health products was only used in our assessment of J&J’s total pharmaceutical revenues. With combined pharmaceutical sales of US$ 47.63 billion, J&J made it to number three on our list.
While the sales of products like Stelara, Darzalex, Imbruvica, Invega Sustenna drove J&J’s pharmaceutical business to grow by 4 percent over 2018, the firm had to contend with generic competition against key revenue contributors Remicade and Zytiga.
US-headquartered Merck, which is known as
MSD (short for Merck Sharp & Dohme) outside the United States and
Canada, is set to significantly move up the rankings next year fueled by its
cancer drug Keytruda, which witnessed a 55
percent increase in sales to US$ 11.1 billion.
Merck reported total revenues of US$ 41.75 billion and also
announced it will spin off its women’s health drugs,
biosimilar drugs and older products to create a new pharmaceutical
company with US$ 6.5 billion in annual revenues.
The firm had anticipated 2020 sales between US$ 48.8 billion and US$ 50.3 billion however this week it announced that the coronavirus pandemic will reduce 2020 sales by more than $2 billion.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Humira holds on to remain world’s best-selling drug
AbbVie’s acquisition of Allergan comes as the firm faces the expiration of patent protection for Humira, which brought in a staggering US$ 19.2 billion in sales last year for
the company. AbbVie has failed to successfully acquire or develop a major new
product to replace the sales generated by its flagship drug.
In 2019, Humira’s US revenues increased 8.6 percent to US$ 14.86 billion while internationally, due
to biosimilar competition, the sales dropped 31.1 percent to US$ 4.30 billion.
Bristol Myers Squibb’s Eliquis, which is also marketed by Pfizer, maintained its number two position
and posted total sales of US$ 12.1 billion, a 23 percent increase over 2018.
While Bristol Myers Squibb’s immunotherapy treatment Opdivo, sold in partnership with Ono in Japan, saw sales increase from US$ 7.57 billion to US$ 8.0 billion, the growth paled in comparison to the US$ 3.9
billion revenue increase of Opdivo’s key immunotherapy competitor Merck’s Keytruda.
Keytruda took the number three spot in drug sales that
previously belonged to Celgene’s Revlimid, which witnessed a sales decline from US$ 9.69 billion to US$ 9.4 billion.
Cancer treatment Imbruvica, which is marketed
by J&J and AbbVie, witnessed a 30 percent increase in sales. With US$ 8.1
billion in 2019 revenues, it took the number five position.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Vaccines – Covid-19 turns competitors into partners
This year has been dominated by the single biggest health emergency in years — the novel coronavirus (Covid-19) pandemic. As drugs continue to fail to meet expectations, vaccine development has received a lot of attention.
GSK reported the highest vaccine sales of all drugmakers with
total sales of US$ 8.4 billion (GBP 7.16 billion), a significant portion of its
total sales of US$ 41.8 billion (GBP 33.754 billion).
US-based Merck’s vaccine division also reported a significant increase in sales to US$ 8.0 billion and in 2019 received FDA and EU approval to market its Ebola vaccine Ervebo.
This is the first FDA-authorized vaccine against the deadly virus which causes
hemorrhagic fever and spreads from person to person through direct contact with
body fluids.
Pfizer and Sanofi also reported an increase in their vaccine sales to US$ 6.4
billion and US$ 6.2 billion respectively and the Covid-19 pandemic has recently
pushed drugmakers to move faster than ever before and has also converted
competitors into partners.
In a rare move, drug behemoths — Sanofi and GlaxoSmithKline (GSK) —joined hands to develop a vaccine for the novel coronavirus.
The two companies plan to start human trials
in the second half of this year, and if things go right, they will file
for potential approvals by the second half of 2021.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Our view
Covid-19 has brought the world economy to a grinding halt and shifted the global attention to the pharmaceutical industry’s capability to deliver solutions to address this pandemic.
Our compilation shows that vaccines and drugs
for infectious diseases currently form a tiny fraction of the total sales of
pharmaceutical companies and few drugs against infectious diseases rank high on
the sales list.
This could well explain the limited range of
options currently available to fight Covid-19. With the pandemic currently infecting
over 3 million people spread across more than 200 countries, we can safely
conclude that the scenario in 2020 will change substantially. And so should our
compilation of top drugs for the year.
View Our Interactive Dashboard on Top drugs by sales in 2019 (Free Excel Available)
Impressions: 55100
This week, Phispers brings you news on GSK, whose new CEO is planning a slew of initiatives to make the British drug giant more competitive. This means more challenges for Luke Miels, AstraZeneca CEO Pascal Soriot’s former deputy who is joining GSK as head of pharma division. Soriot, on the other hand, put all rumors to rest in a memo to his staff. In other news, Donald Trump unveiled a glass vial project that will create more jobs in America. And Teva announced job cuts in Israel. While Momenta-Sandoz lost a case to Amphastar.
GSK overhaul begins under new CEO; AZ’s Soriot puts (Teva) rumors to rest in a memo
Pascal Soriot, chief
executive of AstraZeneca, put all rumors to rest and told his
staff that he expects to work together with them and see the company succeed. A report in the Israeli media earlier this month had
said Soriot was in talks to join Teva. Last week, PharmaCompass reported
that Soriot had dropped the offer.
Though he did not mention Teva, in a memo, Soriot said: “Together, we are poised to achieve something remarkable and that few thought possible…Nothing can break the momentum you have established, and certainly not rumors.”
Soriot
is reportedly attending the European Society for Medical Oncology (ESMO)
annual meeting in Madrid in September, in case AstraZeneca has its clinical
data on its new immunotherapy medicine ready to present at the event.
Meanwhile, Soriot’s deputy, Luke Miels, is joining GlaxoSmithKline as head of its pharma
division. And if news reports are to be believed, employees are going to need courage to work under the Emma Walmsley,
the new CEO of the British drug giant.
Walmsley is looking for ways to make GSK more competitive. And in order to achieve that, she is pushing some functions and a lot of accountability into GSK’s three divisions. Their leaders will own the successes, as well as any failures.
According
to news reports, GSK is selling its Horlicks brand in the UK, shutting the Slough plant
where the malt drink is made and is abandoning a proposed US$ 457 million (£350 million) biopharmaceutical manufacturing plant in Cumbria.
Walmsley
also wants to improve drug research productivity, and wants GSK to have fewer but potentially more lucrative new drug launches in
the future. GSK is planning on scrapping more than 30 drug development programs and will focus 80
percent of its R&D budget on the top candidates in four therapeutic areas
and potentially exit the rare disease space.
Momenta-Sandoz lose case to Amphastar; AbbVie to
pay US$ 150m in damages
In
the US, Amphastar Pharmaceuticals won a case in a federal court against Momenta
Pharmaceuticals Inc and its partner Novartis AG’s Sandoz unit. The two had sought nearly
US$ 940 million in damages against Amphastar.
Momenta
and Sandoz had filed the lawsuit in 2011 after the US Food and Drug Administration (USFDA) had approved Amphastar’s generic version of Sanofi’s blockbuster Lovenox, an anticoagulant used to treat and
prevent blood clots.
The
two companies had accused Amphastar of infringing on a patent held by them,
through the production of a generic version of the blood-thinner Lovenox.
In
a statement, Momenta CEO Craig Wheeler said the company was disappointed and was considering its options, including a potential appeal. “We continue to believe in the importance of investing in innovative techniques for bringing products to market and protecting those innovations from unauthorized use,” he said.
Momenta
and Sandoz suffered a major setback earlier this year when Pfizer’s fill/finish manufacturing facility in
McPherson, Kansas, received a warning letter from the USFDA. The compliance
concern had been initially revealed by Momenta in a press statement as the
company, in collaboration with Sandoz, is developing a generic version of Teva’s
long-acting Copaxone® 40mg/mL (glatiramer acetate injection). Sandoz had tied up with Pfizer as its fill/finish manufacturing
partner.
Copaxone generated US$ 4.22 billion in sales last year.
Meanwhile,
a federal jury in Chicago found AbbVie Inc fraudulently misrepresented the risks of its testosterone replacement drug — AndroGel. The jury ordered AbbVie to pay US$ 150 million in punitive
damages.
A
lawsuit had been filed in 2014 against AbbVie by Jesse Mitchell and his wife.
The decision in the Mitchell case is the first in a series of test trials aimed
at helping plaintiffs and manufacturers of AndroGel assess the range of damages
and define a legal strategy and settlement options for such trials.
The jury said AbbVie was not “negligent or strictly liable” for a heart attack Mitchell suffered after taking AndroGel. However, it said AbbVie falsely marketed the drug. And, it did not award Mitchell compensatory damages for his injuries and losses.
Trump unveils glass vial project that is likely to
create 4,000 jobs in the US
Last
week, the US President Donald Trump announced an initiative to manufacture a
new kind of glass for injectable drug vials. Corning Inc is making a US$ 500 million
investment along with pharma giants Merck and Pfizer to manufacture these vials, which are
likely to create nearly 1,000 jobs at facilities in New York and New Jersey and another ‘yet to be announced’ site in southeastern USA.
This initiative was part of Trump's ‘Made in America’ week, during which he showcased America-made products. Trump also defended his administration’s ‘America First’ policies. He was joined by the
CEOs of Corning, Merck and Pfizer.
Trump said the deal could eventually result in a total investment of US$ 4 billion and create around 4,000 jobs. “This initiative will bring a key industry to our shores that for too long has been dominated by foreign countries. We’re moving more and more companies back into the United States,” Trump said.
According
to Trump, the glass is called Valor Glass and is a “substantial improvement” in
quality over existing products. It has superior strength and is more
damage-resistant.
In Israel, Teva pulls out the job axe; Japan’s Mitsubishi Tanabe buys Neuroderm
Teva
Pharmaceutical Industries recently announced that it is beginning negotiation
with the labor groups in Israel. It is expected to cut 300 to 350 workers and managers at production sites in
Histadrut and Ramat Hovav in the coming months.
This move will be yet another step towards Teva’s restructuring and business focus, aimed at bolstering the competitiveness of its sites in Israel.
Post
this announcement, Histadrut called a work dispute, which will permit employees
to strike in 14 days time. Teva currently has 7,000 employees in Israel.
Histradrut spokesman Yaniv Levy said: “We will not accept any unilateral measure in which workers are laid off at Teva. We expect the company’s management to act responsibly, and not to involve Teva’s plants in Israel in a series of conflicts that will escalate labor relations.”
Meanwhile,
Japan's Mitsubishi Tanabe Pharma has agreed to buy Israeli drug maker
Neuroderm for US$
1.1 billion in cash as part of a strategy to grow its business in the US.
Mitsubishi Tanabe said it is particularly attracted by Neuroderm’s Parkinson’s disease drug that is in advanced clinical trials in the US and Europe and is likely to be launched in 2019.
A minor molecule twist could be the
solution to cancer that killed Steve Jobs
Last
week, a nuclear medicine targeted at the type of cancer that killed former
Apple Inc co-founder and CEO Steve Jobs got a nod from the European Medicines
Agency (EMA), boosting prospects for its developer — Advanced Accelerator Applications (AAA).
The EU drugs regulator said its Committee for Medicinal Products for Human Use (CHMP) had recommended the product — Lutathera (lutetium 177 dotatate). This emerging treatment targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. The drug is likely to get a full approval in the coming two months.
Stefano Buono, chief executive officer of AAA, said
the company was also ready to re-file its application for US marketing approval
with the USFDA this month.
This French biotech company has described the new drug as a “multi-hundred million” dollar opportunity. Lutathera has the potential to transform AAA’s fortunes.
Buono’s AAA, which was spun off from Europe’s physics research centre CERN 15 years ago, had sales from existing diagnostic products of US$ 34.9 million in the first quarter of 2017. Lutathera is unusual in harnessing the same molecule that is already used to diagnose cancer to also deliver treatment.
After Celgene, Cardinal Health pulls out of China due to regulatory concerns
After Celgene
decided to reduce its footprint in China earlier this month, in order to
support only its clinical development and regulatory affairs activities in the
country, this week we heard about US drug distributor Cardinal Health putting its
China business on the block.
As per news reports, state-backed Chinese pharma companies
have evinced interest in a deal that may be worth up to US$ 1.5 billion. Shanghai Pharmaceutical, China Resources Pharmaceutical, and Sinopharm are
among those evincing interest in buying Cardinal Health, one of China’s largest drug distributors.
Ohio-based Cardinal wants to exit the country due to concerns around China's upcoming drug distribution reform, which is likely to slow down its growth. Cardinal has also been diversifying — in April it announced a US$ 6.1 billion deal for Medtronic Plc’s medical supplies units.
It has reportedly hired Lazard as an adviser for the China sale and the first
round of bidding is due later this week.Meanwhile, Celgene is offloading its Chinese operations to
the biopharmaceutical major Beigene. It is also giving Beigene the rights to Abraxane, Revlimid and Vidaza in China. This way, Beigene will assume responsibility for making and selling the approved drugs, along with Celgene’s pipeline prospect CC-122 in China. Celgene had also announced that it would buy a stake in BeiGene to help
develop and commercialize the China-based cancer immunotherapy developer's
treatment for solid tumor cancers, expanding its position in the field of
immuno-oncology. When the deal closes in the third quarter of this year,
Beigene will instantly become a commercial-stage biotech.
Impressions: 2944
GSK, Google form first bioelectronics firm; 11 generic companies benefit from the Teva Allergan deal
This week,
Phispers brings to you the details of the bioelectronics firm formed by GSK and
Google. There is also news on companies like Teva, Takeda, Jinan Jinda and Eli
Lilly, besides two other news snippets pertaining to the FDA -- while the first
one pertains to generic approvals, the other one relates to an additional black
box warning on a few antibiotics. GSK and Google
join hands to form first bioelectronics startupGlaxoSmithKline and Google’s parent company – Alphabet – have joined hands to create a new company that is focused on fighting diseases by targeting electrical signals in the human body. This way, GSK and Alphabet’s life sciences unit – known as Verily Life Sciences – will be jump-starting a new field of medicine known as bioelectronics.Verily Life
Sciences and GSK will together contribute US $ 715.12
million
over seven years to the startup Galvani Bioelectronics. The startup will develop
miniature electronic implants for the treatment of asthma, diabetes and other
chronic conditions. The
implantable devices developed by Galvani, which is owned 55 percent by GSK and
45 percent by Verily, can modify electrical nerve signals. The aim is to
modulate irregular or altered impulses that occur in many illnesses.The
new company
will be based at GSK’s Stevenage research center north of London, with a second research hub in South San Francisco.The announcement comes just weeks after GSK had said it was going to use Apple’s HealthKit to conduct clinical trials.Three years ago, GSK had first unveiled its ambitions in bioelectronics in the journal – Nature. Bioelectronic remedies attach battery-powered implants the size of a grain of rice (or even smaller) to individual nerves to correct faulty electrical signals between the nervous system and the body’s organs.GSK believes altering these nerve signals could open up the airways of asthma patients, reduce inflammation in the gut from Crohn’s disease and treat patients with a range of other chronic ailments such as arthritis. So far, the implants have only been tested on animals but the aim is to produce treatments that will supplement or replace drugs that often come with side-effects.GSK
has been working on bioelectronic medicines since 2012 in a push to develop new
patentable treatments, since its Advair respiratory treatment faces competition
from generic versions. It has invested US $50 million in a venture capital fund
for bioelectronics and provided funding to scientists working in the field. Teva divests 79
products to 11 generic players to close Allergan dealTeva
Pharmaceutical Industries – the world’s largest generics drug company – won a US
anti-trust approval to purchase Allergan's generics
business, after agreeing to divest 79 generic drugs to rival firms. This was arrived
at to settle Federal
Trade Commission (FTC) charges that its proposed US $ 40.5 billion acquisition of Allergan’s generic pharmaceutical business would be anti-competitive. The remedy requires Teva to divest the drug portfolio to 11 firms, and marks the largest drug divestiture order in a FTC pharmaceutical merger case.The Teva-Allergan deal, which was announced in July 2015, solidifies Teva’s position as the world's largest maker of generics while freeing Allergan to focus on branded drugs.The
companies that
have acquired
the divested products are Mayne Pharma
Group, Impax
Laboratories, Dr Reddy’s Laboratories, Sagent
Pharmaceuticals, Cipla Limited, Zydus Worldwide
DMCC, Mikah Pharma, Perrigo Pharma
International, Aurobindo
Pharma USA,
Prasco and 3M Company. Eli Lilly CEO
steps down; company under probe by US Justice Department Eli Lilly CEO John
Lechleiter has stepped down after steering the pharma company through long R&D droughts. The company’s president David Ricks will move up to the top spot. And after a brief spell as executive chairman, Lechleiter will leave the company next spring.Lechleiter
has been the company's CEO since April 1, 2008, and the chairman of its board
of directors since January 1, 2009.The
announcement has come at a time when Eli Lilly has been asked by the
Justice Department to disclose information on relationships with pharmacy benefits
managers (PBMs), the companies that negotiate prices and set reimbursement
conditions.It
has not been clear what exactly the department of justice is looking for. In
the past, drug makers such as Novartis and AstraZeneca have agreed to
pay fines and penalties to settle allegations pertaining to PBMs. FDA continues
to race ahead with generic approvals The
American regulator has reduced its pile of ANDA (abbreviated new drug
applications) by about 500
applications in the first six months of 2016. The FDA has also approved 315 more ANDAs over the same time period and has sent 66 more complete response letters — or rejections — to drug makers.This
news comes after Bloomberg reported
last month that the FDA has become ‘something of a bogeyman’ for India’s stock markets by approving generic drug applications from India at a record place. Similarly, PharmaCompass
had reported last week that Indian
companies have been fixing compliance issues. China’s Jinan Jinda fails another EDQM inspection; compliance troubles in Denmark In
regulatory news from across the world, Jinan Jinda, a Chinese API
manufacturer that had failed an inspection by Italian regulators in June 2015,
had more bad news awaiting it a year on. In
a June 2016
re-inspection, this time by the Spanish Health Authority, the regulator maintained the ‘facilities non-compliance standing’ since two critical observations were made and the corrections from the previous inspection “were found as not having been implemented in a satisfactory way”. And critical deficiencies were found on raw data.In
the June 2015 inspection, the critical observation was related to an unofficial
and non-controlled storage area containing mainly raw materials and finished
products which had been made
inaccessible to inspectors as the door had been removed and replaced with a panel fixed with
screws to the wall.Meanwhile,
the FDA issued an untitled letter (dated July 15, 2016) to Danish allergy
immunotherapy company ALK-Abelló (ALK) over manufacturing and quality control issues at its Horsholm, Denmark facility. The letter comes after a 12-day inspection of the facility in March 2016. During the inspection, the FDA had cited ALK for four “significant deviations” from cGMP requirements. Another black
box warning added to antibiotics like Cipro and LevaquinThe
FDA has upgraded
warnings on
certain antibiotics, such as Johnson & Johnson’s Levaquin, Bayer’s Cipro
extended-release tablets and Merck’s Avelox. The FDA had
added a black box warning in 2008 about the increased risk of tendinitis in
which the tissue connecting muscle to bone becomes inflamed. In
May this year, the FDA had advised restricting the use of fluoroquinolone antibiotic for certain uncomplicated
infections and had warned about the disabling side-effects of the drug.The new warning talks about long-term risks to the drugs’ current black box warning. The agency also advised using the drugs only for serious infections. Manufacturers of fluoroquinolone have faced thousands of lawsuits from patients who claim that their injuries were caused by the drugs. J&J alone faced 3,400 lawsuits over Levaquin’s links to tendon problems and has also settled many of those cases. Takeda to
overhaul R&D, downsize operations in the UKTakeda Pharmaceutical of Japan has
said it plans to build a new pipeline of drugs. It plans to revamp its
research operations at the cost of around US $ 727 million.. The
company also plans to close some of its R&D operations in the UK. Takeda is
beginning the first ‘consultation stage’ of the layoff process in the UK, which hosts a pre-clinical R&D operation in Cambridge as well as a development center headquarter with facilities in the UK, Switzerland and Denmark.Under the revamp, Takeda’s R&D activities will be concentrated in Japan and the US, the 235-year old drug company said in a statement. Takeda plans to now focus on the three therapeutic areas of oncology, gastroenterology and the central nervous system.“We need to first build new capabilities and embrace new ways of working,” Andy Plump, Takeda’s chief medical and scientific officer, said in the statement.
Impressions: 2803
Legally
cultivated cannabis, in some parts of the United States, resulted in a boom,
which could never have been previously imagined. Just last year, there were so
many growers that, in the state of Washington alone, more
than 20,000 kg of marijuana (cannabis) was available, which didn’t have any takers!Last year also saw the stock
market recognize the value of little known, GW
Pharmaceuticals, a UK based company, focused on developing medicines from
marijuana. Their product, Sativex, already
approved in 27 countries is currently awaiting USFDA approval. With Wall Street valuing GW Pharmaceuticals at almost $2
billion, is there a future for marijuana based medicines? Increasing production
of legal marijuanaMarijuana or cannabis, is ‘still’ classified as schedule 1 drug, which means that the Drug Enforcement Agency (DEA), believes there is no currently accepted medical use and the drug isn’t safe to use even under medical supervision. However, with all the research interest, the DEA has proposed a
massive increase in the amount of marijuana production. It will hopefully
allow, that the demands of the researchers will finally be met. Highly
curative?There
are two key active ingredients inside Marijuana, Cannabidiol (CBD) and Tetrahydrocannabinol (THC). While the potency of marijuana is linked to the amount of Tetrahydrocannabinol (THC) inside it, Cannabidiol (CBD) which isn’t responsible for the high, is the one considered to have the wider scope for medical applications. Epidiolex// treatment of epilepsy in
children?An orally-administered liquid
containing CBD has received orphan drug status in the US, under the brand name Epidiolex. GW Pharmaceuticals, the
developer of Epidiolex is also performing their second
Phase III clinical trial to demonstrate its effectiveness in the treatment
of epilepsy in children. Sativex// treatment
of spasticitySativex, a mixture of THC and CBD, is approved for sales in
countries for the treatment of spasticity (muscle spasms and stiffness) related
to multiple sclerosis; a disease that affects 1.3 million people worldwide, of
which up to 80% suffer from spasticity.In addition to THC and CBD, GW
Pharmaceuticals, has also developed a portfolio of products based on the other
cannabinoids found in the plant. Marinol// approved in
1985GW Pharmaceuticals isn’t alone since synthetic derivatives of THC have also been on the market for years. Dronabinol
(brand name: Marinol), approved in 1985 for prevention of nausea and vomiting
during chemotherapy, is estimated to have current sales
of almost $450 million. After the initial launch, the
product also got approval for appetite and weight loss in patients with HIV/AIDS.
The product got reclassified, in
1998 by the DEA, from a Schedule II drug to a Schedule III one which allowed
access to a wider patient base. An open ‘high-way’ for businessInsys
Therapetuics, another player in this space, who had their novel,
more bio-available formulation of Dronabinol rejected by the FDA, still commands a market valuation of almost $3
billion. Plant based medicines, like Paclitaxel,
Docetaxel,
Morphine,
Codeine
have made billions for the pharmaceutical industry in the past and the market
valuations of GW Pharmaceuticals and Insys Therapeutics indicates similar
expectations for developing medicines from marijuana. With many other cannabinoids in the plant, raw material
availability no longer as restricted as in the past, licensing
opportunities on new indications available from the National Institute of Health (NIH)– it is just a matter of who hits the marijuana ‘high-way’ first?
Impressions: 2391
Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3160
Many companies have been actively developing Cabazitaxel (Jevtana Kit®), a prostate cancer drug that belongs to the same class of molecules as off-patent blockbusters Paclitaxel (Taxol®) and Docetaxel (Taxotere®).
Sanofi, the originator, has been struggling with sales of this molecule, as it has never lived up to its blockbuster expectations, with lackluster global sales of 273 million euros in 2014. The major part of the sales, 142 million euros, have been in Europe, where sales showed an increase of 28.2% over the previous year. Sales last year in the United States, on the other hand, grew only 5.8% and were 91 million euros.
Lately, Sanofi received notice when Breckenridge Pharmaceutical, Inc., announced Paragraph IV ANDA litigation (1st generic filing) for Cabazitaxel. The first generic challenge followed the National Health Services’ (NHS) decision in the UK to remove the drug from the Cancer Drugs Fund approved list of medicines, because of its poor cost-effectiveness. Cabazitaxel, most often used after Docetaxel treatment (against cancers) has failed, has been priced at about $5,500 per treatment cycle, which is almost twice the cost of Docetaxel.
With almost 9 companies having filed USDMFs for the different polymorphs of Cabazitaxel and significant development activity on this product in India, as shown by the import-export trade data, it remains to be seen if the investment will provide the anticipated returns, since Sanofi definitely does not seem to be having the same experience.
Impressions: 6149